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    The EU Clinical Trials Register currently displays   44306   clinical trials with a EudraCT protocol, of which   7355   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-000328-42
    Sponsor's Protocol Code Number:CP-104
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-06-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2007-000328-42
    A.3Full title of the trial
    A clinical pharmacology study to determine the pharmacokinetic , safety and tolerability profile and antiviral activity of multiple oral doses of A-831 in otherwise healthy male Hepatitis C carriers with compensated liver disease.
    A.3.2Name or abbreviated title of the trial where available
    Clinical pharmacology study of A-831 in Hepatitis C carriers
    A.4.1Sponsor's protocol code numberCP-104
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorArrow Therapeutics Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameA-831/Hydroxypropyl methyl cellulose in bottles
    D.3.2Product code A-831/Hydroxypropyl methyl cellulose
    D.3.4Pharmaceutical form Granules for oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeA-831
    D.3.9.3Other descriptive name[6-(3,4-Dimethoxy-phenyl)-quinazolin-4-yl]-(4-[1,2,4]triazol-1-yl-phenyl)-amine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGranules for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Male Hepatitis C carriers with compensated liver disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the pharmacokinetic profiles of multiple, oral doses of A-831 in male Hepatitis C carriers

    To determine the safety and tolerability of multiple, oral doses of A-831 in male Hepatitis C carriers
    E.2.2Secondary objectives of the trial
    To determine the antiviral activity of multiple, oral doses of A-831 in male Hepatitis C carriers as measured by Q-RT-PCR for HCV RNA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Volunteers will be males of any race aged 18-60 years with a BMI between 18 and 32 kg/m2 at the time of the screening medical

    Volunteers who have given their written informed consent to participate in the study

    Volunteers who are willing and able to comply with the protocol and study procedures

    Volunteers who have a diagnosis of chronic hepatitis C infection (genotype Ia or 1b) confirmed by documentation of the presence of circulating hepatitis C virus by a hepatitis C PCR test with viral RNA load of ≥ 100 000 IU/mL (by Taqman assay)

    Volunteers must be in good health (other than history of Hepatitis C infection) as determined by a medical history, medical examination, electrocardiograph, serum biochemistry, haematology, urinalysis, and serology (Hepatitis B and HIV).

    If previously treated for hepatitis C infection, subjects must have completed treatment at least 6 months before screening.
    E.4Principal exclusion criteria
    Volunteers who have taken any prescribed systemic or topical medication, within 14 days or any over the counter medication within 7 days of the start of dosing (excluding paracetamol). Over the counter medication, which in the opinion of the Investigator will not interfere with the objectives of this study, will be permitted.

    Volunteers who have donated any blood or plasma in the last 3 months, or in excess of 1100mL of blood within the 12 months preceding screening

    Volunteers who have received an investigational drug within 3 months (90 days) preceding the start of dosing

    Volunteers who have any significant history of drug allergies

    Volunteers who have any clinically significant allergic disease (excluding non-active hayfever)

    Volunteers who have a supine blood pressure, after resting for 5 min, higher than 145 mmHg for systolic, 90 mmHg for diastolic blood pressure or lower than 90 mmHg for systolic, 45 mmHg for diastolic blood pressure

    Volunteers who have a supine pulse, after resting for 5 min, outside the range of 40 to 90 beats/min

    Volunteers who have consumed more than 28 units of alcohol per week in the three months prior to the screening medical

    Volunteers who smoke more than 10 cigarettes per day

    Volunteers with, or a history of, clinically significant neurological, gastrointestinal, cardiovascular, pulmonary, metabolic, endocrine, haematological or other major disorders, excluding Hepatitis C infection.

    Volunteers with a previous episode of psychosis or suicide attempt or who have been treated with antidepressant medication within the past six months.

    Volunteers who, in the opinion of the Investigator have any clinically significant abnormal laboratory tests. All volunteers must have:
    ALT, GGT and AST results ≤ 5 x ULN ,
    total bilirubin results ≤ 20 µmol/L (or genotypic evidence of Gilberts syndrome)
    Alkaline Phosphatase results ≤ 3 x ULN.

    Volunteers with decompensated liver disease or histological or clinical evidence of cirrhosis are excluded. Clinical evidence includes:
    abnormal bilirubin
    low albumin (<3.5g/dL)
    low platelet count (<140,000/mm3)
    clinical syndromes of decompensated liver disease at any point in the patient’s history.

    Volunteers who have evidence of hepatocellular carcinoma or an alpha-fetoprotein of >50µg/mL

    Volunteers who have had any surgery of the gastrointestinal tract likely to affect drug absorption

    Volunteers who have had a clinically significant acute illness within 4 weeks of the start of dosing

    Volunteers, who in the opinion of their general practitioner, hepatologist or the Investigator, should not participate in the study

    Volunteers with confirmed positive and clinically significant drugs of abuse test
    E.5 End points
    E.5.1Primary end point(s)
    Please refer to primary and secondary objectives
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 36
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not Applicable
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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